E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Carcinoma de células renales |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038395 |
E.1.2 | Term | Renal carcinoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the INSPIRE study is to evaluate the overall survival of patients who participated in the Antigenics C-100-12 (part I) study. |
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E.2.2 | Secondary objectives of the trial |
To describe investigator-reported disease recurrence for patients who, at time of the study closure of Antigenics C-100-12 (part I) study, were reported by the investigator as being disease-free. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible, patients must have 1. Participated in the Antigenics C-100-12 (part I) protocol, and terminated the study with last survival status reported as 'alive' and due to 'administrative study closure'
2. Signed an informed consent to participate in the C-100-27 Survival Follow-up protocol, and be willing to receive contact from a representative from the protocol investigative study centers and/or any subsequently identified co-investigator sites where patients consent to continued survival follow-up and/or a member from a company designated by the Sponsor every 6 months if no disease recurrence and every 3 months if disease has recurred. |
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E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
- the duration of survival, reported as date of death. Date of death is to include, at minimum, the month and year of death. - If available, additional endpoint data for cause of death will be reported as progression of renal cell carcinoma, other disease or unknown. - If available, endpoint data for disease recurrence will be reported as confirmed disease recurrence, absent disease recurrence or unknown. In addition, the date of recurrence will be reported, per the investigator, as the earliest date of radiologic or nonradiologic evaluation that identified the lesion subsequently determined to be recurrence of renal cell carcinoma.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The C-100-27 Survival Follow-up will be conducted for up to 3 years from the date of the Antigenics C-100-12 (Part I) protocol study closure, which took place on March 30, 2007. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |